A Randomized, Active-Controlled, Double-Blind, Phase 3 Study to Compare Efficacy and Safety of CT-P55 With Cosentyx in Patients With Moderate to Severe Plaque Psoriasis
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 发起方
- Celltrion
- 入组人数
- 153
- 试验地点
- 1
- 主要终点
- Percent change from baseline in Psoriasis Area and Severity Index (PASI) score
研究概览
简要总结
The goal of this Phase 3 clinical trial is to compare efficacy and safety of CT-P55 with Cosentyx in patients with moderate to severe plaque psoriasis
详细描述
CT-P55 is a recombinant humanized monoclonal antibody containing the active ingredient secukinumab. CT-P55 is a drug product being developed by CELLTRION, Inc. and being compared to the EU-approved Cosentyx®. In this study, Efficacy and Safety of CT-P55 will be evaluated in patients with Moderate to Severe Chronic Plaque Psoriasis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •- Patient has had a diagnosis of chronic plaque psoriasis for at least 24 weeks.
排除标准
- •Patient diagnosed with forms of psoriasis other than chronic plaque-type or medication-induced psoriasis.
- •Patient who has previously received Secukinumab or any other biologic drug directly targeting Interleukin-17 or the IL-17 receptor.
- •Patient who has allergies to any of the excipients of study drug or materials of device or any other murine and human proteins, or patient with a hypersensitivity to immunoglobulin products.
研究组 & 干预措施
CT-P55
干预措施: CT-P55 (Biological)
EU-approved Cosentyx
干预措施: CT-P55 (Biological)
EU-approved Cosentyx
干预措施: EU-approved Cosentyx (Biological)
结局指标
主要结局
Percent change from baseline in Psoriasis Area and Severity Index (PASI) score
时间窗: Week8
A higher percent change indicates a better outcome. While the maximum value is 100%, the minimum value is not fixed and may be negative in cases of worsening symptoms.
次要结局
- Proportion of patients who achieve at least 50/75/90/100% improvement from baseline in PASI (PASI 50/75/90/100)(Up to 56 Weeks)
- Actual PASI scores(Up to 56 Weeks)
- Percent change from baseline in PASI score(Up to 56 Weeks)
- Change from baseline in Dermatology Life Quality Index (DLQI)(Up to 56 Weeks)
- Proportion of patients with Investigator's Global Assessment (IGA) score of clear (0) or almost clear (1)(Up to 56 Weeks)